Compositions and methods for enhancing therapeutic effects

ABSTRACT

Compositions and methods for enhancing the effects of therapeutic compositions are provided. The compositions comprise singly or in combination herbals, natural nutritional supplements, minerals and vitamins.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. ProvisionalApplication Ser. No. 60/208,990, filed Jun. 1, 2000, hereby incorporatedin its entirety by reference.

TECHNICAL FIELD

[0002] This invention relates to compositions and methods for enhancingtherapeutic effects. More specifically, it relates to nutraceuticalcompositions for enhancing the therapeutic effects of anothercomposition, and methods for enhancing therapeutic effects.

BACKGROUND ART

[0003] The need for enhancement of therapeutic effects of therapeuticsubstances or compositions is particularly apparent where conventionalherbal and natural nutritional supplements are used to achieve theseeffects. These substances act slowly, and are considered primarily toprovide individuals with long term benefits rather than short term orimmediate improvement in the medical condition in question. Althoughpharmaceutical drugs have generally been considered to be more effectivein treating acute conditions, this treatment often has significant sideeffects. Non-pharmaceutical alternatives, such as nutraceuticals, areoften preferred because of their safer or more long-lasting effects.This usually means, however, that in choosing these alternativeapproaches, the treated individual has to forego more immediatealleviation of symptoms that might otherwise have been achievablethrough the use of pharmaceuticals.

[0004] It would, therefore, clearly be advantageous to have herbal andnatural nutritional supplements that can provide therapeutic effectssimilar in intensity and immediacy to pharmaceutical drugs, whilecontinuing to provide long term health benefits and with the avoidanceof significant side effects. The invention described and claimed in thisspecification provides this advantage by presenting compositions andmethods for enhancing the therapeutic effects of conventional herbal andnatural nutritional supplements.

[0005] All references cited herein, including patent applications andpublications, are incorporated by reference in their entirety.

DISCLOSURE OF THE INVENTION

[0006] Compositions and methods for enhancing effects of therapeuticcompositions are provided. The compositions comprise substances inquantities that are effective for enhancing the therapeutic effects ofcompositions with which they are administered in combination. Methods ofenhancing therapeutic effects of a composition comprising administrationof the claimed compositions are also provided. Methods of makingcompositions of the invention are also provided.

[0007] Accordingly, in one aspect, the invention provides a firstcomposition for enhancing the therapeutic effects of a secondcomposition, said first composition comprising a substance selected fromthe group consisting of a member of the botanical group Daemonorops anda member of the botanical group Corydalis.

[0008] In another aspect, the invention provides a first composition forenhancing the therapeutic effects of a second composition, said firstcomposition comprising a member of the botanical group Daemonorops and amember of the botanical group Corydalis.

[0009] In one embodiment, the invention provides a composition selectedfrom a group consisting of the first compositions of the aspects of theinvention described in the preceding paragraphs, further comprising asubstance selected from the group consisting of a member of thebotanical group Paeonia, a member of the botanical group Panax, a memberof the botanical group glycyrrhiza, white willow bark, a member of thebotanical group Cimicifuga, L-carnitine, vitamin E and vitamin C. Thus,for example, in one embodiment, a composition comprises a member of thebotanical group Daemonorops and a member of the botanical group Panax.In some of these embodiments, the composition comprises xuejie andshanqi. In another example, a composition comprises a member of thebotanical group Corydalis and a member of the botanical group Panax. Insome of these embodiments, the member of the botanical group Corydalisis yanhusuo and the member of the botanical group Panax is shanqi.

[0010] In another embodiment, the invention provides a compositionselected from a group consisting of the aspects of the inventiondescribed in the preceding paragraphs, further comprising 2 substancesselected from the group consisting of a member of the botanical groupPaeonia, a member of the botanical group Panax, a member of thebotanical group glycyrrhiza, white willow bark, a member of thebotanical group Cimicifuga, L-carnitine, vitamin E and vitamin C.

[0011] In another embodiment, the invention provides a compositionselected from a group consisting of the aspects of the inventiondescribed in the preceding paragraphs, further comprising 3 substancesselected from the group consisting of a member of the botanical groupPaeonia, a member of the botanical group Panax, a member of thebotanical group glycyrrhiza, white willow bark, a member of thebotanical group Cimicifuga, L-carnitine, vitamin E and vitamin C.

[0012] In another embodiment, the invention provides a compositionselected from a group consisting of the aspects of the inventiondescribed in the preceding paragraphs, further comprising 4 substancesselected from the group consisting of a member of the botanical groupPaeonia, a member of the botanical group Panax, a member of thebotanical group glycyrrhiza, white willow bark, a member of thebotanical group Cimicifuga, L-carnitine, vitamin E and vitamin C.

[0013] In another embodiment, the invention provides a compositionselected from a group consisting of the aspects of the inventiondescribed in the preceding paragraphs, further comprising 5 substancesselected from the group consisting of a member of the botanical groupPaeonia, a member of the botanical group Panax, a member of thebotanical group glycyrrhiza, white willow bark, a member of thebotanical group Cimicifuga, L-carnitine, vitamin E and vitamin C.

[0014] In another embodiment, the invention provides a compositionselected from a group consisting of the aspects of the inventiondescribed in the preceding paragraphs, further comprising 6 substancesselected from the group consisting of a member of the botanical groupPaeonia, a member of the botanical group Panax, a member of thebotanical group glycyrrhiza, white willow bark, a member of thebotanical group Cimicifuga, L-carnitine, vitamin E and vitamin C.

[0015] In another embodiment, the invention provides a compositionselected from a group consisting of the aspects of the inventiondescribed in the preceding paragraphs, further comprising 7 substancesselected from the group consisting of a member of the botanical groupPaeonia, a member of the botanical group Panax, a member of thebotanical group glycyrrhiza, white willow bark, a member of thebotanical group Cimicifuga, L-carnitine, vitamin E and vitamin C.

[0016] In another embodiment, the invention provides a compositionselected from a group consisting of the aspects of the inventiondescribed in the preceding paragraphs, further comprising a member ofthe botanical group Paeonia, a member of the botanical group Panax, amember of the botanical group glycyrrhiza, white willow bark, a memberof the botanical group Cimicifuga, L-carnitine, vitamin E and vitamin C.

[0017] In some embodiments of the compositions of the aspects of theinvention described in the preceding paragraphs, the member of thebotanical group Daemonorops is xuejie and/or the member of the botanicalgroup Corydalis is yanhusuo. In some embodiments of the compositions ofthe aspects and embodiments of the invention described in the precedingparagraphs, the member of the botanical group Daemonorops is xuejie, themember of the botanical group Corydalis is yanhusuo, the member of thebotanical group Paeonia is baishaoyao, the member of the botanical groupPanax is shanqi, the member of the botanical group glycyrrhiza isgancao, and/or the member of the botanical group Cimicifuga is blackcohosh.

[0018] Accordingly, in one aspect, the invention provides a firstcomposition for enhancing the therapeutic effects of a secondcomposition, said first composition comprising a substance selected fromthe group consisting of xuejie and yanhusuo.

[0019] In another aspect, the invention provides a first composition forenhancing the therapeutic effects of a second composition, said firstcomposition comprising xuejie and yanhusuo.

[0020] In one embodiment, the invention provides a composition selectedfrom the group consisting of the first compositions of the aspects ofthe invention described in the preceding paragraphs, further comprisinga substance selected from the group consisting of baishaoyao, shanqi,gancao, white willow bark, black cohosh root, L- carnitine, vitamin Eand vitamin C.

[0021] In another embodiment, the invention provides a compositionselected from the group consisting of the first compositions of theaspects of the invention described in the preceding paragraphs, furthercomprising 2 substances selected from the group consisting ofbaishaoyao, shanqi, gancao, white willow bark, black cohosh root,L-carnitine, vitamin E and vitamin C.

[0022] In another embodiment, the invention provides a compositionselected from a group consisting of the first compositions of aspects ofthe invention described in the preceding paragraphs, further comprising3 substances selected from the group consisting of baishaoyao, shanqi,gancao, white willow bark, black cohosh root, L- carnitine, vitamin Eand vitamin C.

[0023] In another embodiment, the invention provides a compositionselected from the group consisting of the first compositions of theaspects of the invention described in the preceding paragraphs, furthercomprising 4 substances selected from the group consisting ofbaishaoyao, shanqi, gancao, white willow bark, black cohosh root,L-carnitine, vitamin E and vitamin C.

[0024] In another embodiment, the invention provides a compositionselected from the group consisting of the first compositions of theaspects of the invention described in the preceding paragraphs, furthercomprising 5 substances selected from the group consisting ofbaishaoyao, shanqi, gancao, white willow bark, black cohosh root,L-carnitine, vitamin E and vitamin C.

[0025] In another embodiment, the invention provides a compositionselected from the group consisting of the first compositions of theaspects of the invention described in the preceding paragraphs, furthercomprising 6 substances selected from the group consisting ofbaishaoyao, shanqi, gancao, white willow bark, black cohosh root,L-carnitine, vitamin E and vitamin C.

[0026] In another embodiment, the invention provides a compositionselected from the group consisting of the first compositions of theaspects of the invention described in the preceding paragraphs, furthercomprising 7 substances selected from the group consisting ofbaishaoyao, shanqi, gancao, white willow bark, black cohosh root,L-carnitine, vitamin E and vitamin C.

[0027] In another embodiment, the invention provides a compositionselected from the group consisting of the first compositions of theaspects of the invention described in the preceding paragraphs, furthercomprising baishaoyao, shanqi, gancao, white willow bark, black cohoshroot, L-carnitine, vitamin E and vitamin C.

[0028] In one embodiment, the invention provides a first composition forenhancing therapeutic effects of a second composition comprising xuejie,yanhusuo, baishaoyao, shanqi, gancao, white willow bark, black cohoshroot, L-carnitine, vitamin E and vitamin C.

[0029] In some embodiments of the compositions of the inventiondescribed herein, said compositions further comprise zinc and/orselenium.

[0030] In various aspects and embodiments of the compositions of theinvention, the second composition whose therapeutic effects are enhancedby the compositions of the invention is effective for treating acondition selected from the group consisting of an eye discomfortcondition, a wrist discomfort condition, a neck and shoulder discomfortcondition, and a back and leg discomfort condition. In some embodiments,compositions of the invention are effective for enhancing cellularmetabolism. In some embodiments, the compositions of the invention areeffective for enhancing blood circulation, reducing cellular/tissueinflammation and/or reducing pain.

[0031] In one aspect, the invention provides methods for enhancingeffects of a therapeutic composition comprising co-administering aneffective amount of a composition selected from the group consisting ofthe compositions of the invention disclosed in the preceding paragraphswith said therapeutic composition, whereby the effects of saidtherapeutic composition are enhanced.

[0032] In still another aspect, the invention provides methods of makinga composition for enhancing effects of a therapeutic composition, saidmethod comprising combining at least one (for example, 1 or 2) substance(preferably in an effective amount) selected from the group consistingof a member of the botanical group Daemonorops and a member of thebotanical group Corydalis with at least one (preferably 1, 2, 3, 4, 5,6, 7 or 8) substance (preferably in an effective amount) selected fromthe group consisting of a member of the botanical group Paeonia, amember of the botanical group Panax, a member of the botanical groupglycyrrhiza, white willow bark, a member of the botanical groupCimicifuga, L-carnitine, vitamin E and vitamin C. In some embodiments,the methods comprise combining a member of the botanical groupDaemonorops and a member of the botanical group Corydalis. In variousembodiments of the these methods, the member of the botanical groupDaemonorops is xuejie, the member of the botanical group Corydalis isyanhusuo, the member of the botanical group Paeonia is baishaoyao, themember of the botanical group Panax is shanqi, the member of thebotanical group glycyrrhiza is gancao, and/or the member of thebotanical group Cimicifuga is black cohosh. In some embodiments, saidcombining is by mixing (such as by stirring, agitation or vibration). Insome embodiments, the substances are packaged in the form of capsules,preferably in size “0”, “00”, “000”, “1”, “2”, “3” or “4.” In yet otherembodiments, the substances are combined in powder form, preferably toat least 30%, 60%, or 90% mixture consistency, or to homogeneity.

MODES FOR CARRYING OUT THE INVENTION

[0033] The present invention discloses compositions comprising single ormultiple substances that are effective and safe for enhancing thetherapeutic effects of another composition when administered incombination. The invention further provides methods for enhancingtherapeutic effects of compositions comprising co-administering thecompositions of this invention with a therapeutic composition.

[0034] Definitions

[0035] The term “treating,” “treatment,” and variations thereof, as usedin this specification, refers to an approach for obtaining beneficial ordesired physiological results, which may be established clinically. Forpurposes of this invention, beneficial or desired clinical resultsinclude, but are not limited to, alleviation of symptoms, diminishmentof extent of disease, stabilized (i.e., not worsening) condition, delayor slowing of progression or worsening of condition/symptoms,amelioration or palliation of the condition or symptoms, and remission(whether partial or total), whether detectable or undetectable. The term“palliation”, and variations thereof, as used herein, means that theextent and/or undesirable manifestations of a physiological condition orsymptom are lessened and/or time course of the progression is slowed orlengthened, as compared to not administering compositions of the presentinvention.

[0036] A “treatment effect” or “therapeutic effect” is manifested ifthere is a change in the condition being treated, as measured by thecriteria constituting the definition of the terms “treating” and“treatment.” There is a “change” in the condition being treated if thereis at least 10% improvement, preferably at least 25%, more preferably atleast 50%, even more preferably at least 75%, and most preferably atleast 100%. The change can be based on improvements in the severity ofthe treated condition in an individual, or on a difference in thefrequency of improved conditions in populations of individuals with andwithout treatment with the therapeutic compositions with which thecompositions of the present invention are administered in combination. A“therapeutic composition” is a composition administered to achieve atreatment or therapeutic effect.

[0037] The term “enhancing,” and variations thereof, as used in thisspecification, refers to an increase in the therapeutic effects of acomposition above those normally obtained when the therapeuticcomposition is administered without the compositions of this invention.“An increase in the therapeutic effects” is manifested when there is anacceleration and/or increase in intensity and/or extent of thetherapeutic effects obtained with a therapeutic composition. It alsoincludes extension of the longevity of therapeutic benefits. It can alsomanifest where a lower amount of the therapeutic composition is requiredto obtain the same benefits and/or effects when it is co-administeredwith compositions provided by the present invention as when a higheramount of the therapeutic composition is administered alone. Theenhancing effect preferably, but not necessarily, results in treatmentof acute symptoms for which the therapeutic composition alone is noteffective or is less effective therapeutically. Enhancement is achievedwhen there is at least a 10% increase in the therapeutic effects when acomposition of the present invention is co-administered with atherapeutic composition compared with administration of the therapeuticcomposition alone. Preferably the increase is at least 25%, morepreferably at least 50%, even more preferably at least 75%, mostpreferably at least 100%.

[0038] An “effective amount” is an amount of a composition orsubstance(s) sufficient to enhance the effects of a therapeuticcomposition after one or more administrations of that amount. Aneffective amount can be administered in one administration, or throughmultiple administrations of an amount that total an effective amount,preferably within a 24-hour period. It can be determined using standardclinical procedures for determining appropriate amounts and timing ofadministration. It is understood that the “effective amount” can be theresult of empirical and/or individualized (case-by-case) determinationon the part of the treating health care professional and/or individual.

[0039] “Co-administering” or “co-administration” of compositions, asused herein, refers to the administration of a composition of thepresent invention and a therapeutic composition within a certain timeperiod. The time period is preferably 12 hours, more preferably 6 hours,still more preferably 3 hours. These terms most preferably mean thecompositions are administered together.

[0040] “Blood circulation,” as used herein, generally refers to thecourse of the blood from the heart through the arteries, capillaries,and veins back again to the heart. “Microcirculation,” as used herein,refers to the circulation of blood in and/or through microvessels (suchas capillaries) and/or circulation of blood within a tissue/organ. Bloodcirculation or microcirculation is “enhanced” when at least one of thecriteria that define blood circulation and/or microcirculation isenhanced. These criteria are known in the art, for example, plasmaviscosity, blood pressure and blood viscosity. There is enhancement ofany of these criteria when there is preferably at least 10%, morepreferably at least 30%, even more preferably at least 50%, and mostpreferably at least 75% increase in the measurement of any of thesecriteria.

[0041] “Metabolism,” “cellular metabolism,” and “intracellularmetabolism,” as used herein, refers to metabolic reactions and/orprocesses in the body, as understood in the art. It generally refers tothe sum of the chemical and/or physical changes occurring in tissue,consisting of anabolism (those reactions that convert small moleculesinto large) and catabolism (those reactions that convert large moleculesinto small), including both endogenous large molecules as well asbiodegradation of xenobiotics. Metabolism, cellular metabolism, andintracellular metabolism is “enhanced” when at least one of the criteriathat define metabolism is enhanced. These criteria are known in the art,for example, production rate/level of pyruvate, acetyl CoA, andadenosine triphosphate. There is enhancement of any of these criteriawhen there is preferably at least 10%, more preferably at least 30%,even more preferably at least 50%, and most preferably at least 75%increase in the measurement of any of these criteria.

[0042] “Individual,” as used herein, refers to a vertebrate, preferablya mammal, more preferably a human.

[0043] A “botanical group,” as used herein, refers to a group ofbotanical entities that are capable of providing similar physiologicaleffect(s) in the compositions of the invention. These botanical entitiesmay or may not belong to the same botanical classification (such asgenus, family).

[0044] “Xuejie,” as used herein, refers to extracts of xuejie. It isalso known as sanguis draconis and Daemonorops droco B1. A member of thebotanical group Daemonorops is a substance that is capable of providinga similar physiological effect(s) as that provided by xuejie in thecompositions of the invention, and is preferably selected from a groupcomprising Sanguis draconis Daemonorops droco B1.; Daemonorops draco B1(xuejie); Dracaena cambodiana Pierre; Dracaena cinnabari Balf; Dracaenadraco Linn.; Dracaena schizantha Baker; Dracaena dihynophyllus; Dracaenamicracanthus Becc.; Dracaena propinqus Becc.; Dracaena draconcellusBecc.; Dracaena motleyi Becc.; Dracaena sparsiflorus Becc.; Pterocarpusdraco Linn.; Croton draco Schlecht; Croton hibiscifolius kunth; Crotonsanguifluus H. B. et K Nov.; Croton gossypiifolius Vahl.

[0045] “Yanhusuo,” as used herein, refers to extracts of yanhusuo. It isalso known as Rhizoma corydalis yanhusuo and Corydalis yanhusuo W. T.Wang. A member of the botanical group Corydalis is a substance that iscapable of providing a similar physiological effect(s) as that providedby yanhusuo in the compositions of the invention, and is preferablyselected from a group comprising Rhizoma corydalis yanhusuo; Corydalisyanhusuo W. T. Wang.; Corydalis yanhusuo W. T. Wang (yanhusuo);Corydalis amabilis Migo; Corydalis amabigua Cham. et Schlecht. Varamurensts Maxim; Corydalis turtschaninovii Bess.; Corydalisturtschaninovii f. yanhusuo; Corydalis schangini (Pall.) B.; Corydalisglaucescens Rg1.; Corydalis ledebouriana Kar. Et Kir.

[0046] “Baishaoyao,” as used herein, refers to extracts of baishaoyao.It is also known as Radix paeoniae lactiflorae and paeonia lactifloraPall. A member of the botanical group Paeonia is a substance that iscapable of providing a similar physiological effect(s) as that providedby baishaoyao in the compositions of the invention, and is preferablyselected from a group comprising Radix paeoniae lactiflorae; Radixpaeoniae rubra; Radix paeoniae veitchii; Paeonia lactiflora Pall;Paeonia albriflora Pall; Paeonia veitchii Lynch; Paeonia lactifloraPall. Var. trichocarpa (Bunge) Stern.; Paeonia obovata. Maxim; Paeoniaanomala; Paeonia hybrida Pall; Paeonia veitchii var woodwardii; Paeoniaedulis (Salisb.); Paeonia officinalis Thunb.

[0047] “Shanqi,” as used herein, refers to extracts of shanqi. It isalso known as Radix Notoginsheng and Panax notoginsheng (Burk.) F. H.Chen. A member of the botanical group Panax is a substance that iscapable of providing a similar physiological effect(s) as that providedby shanqi in the compositions of the invention, and is preferablyselected from a group comprising Radix notoginsheng; Panax notoginsheng(Burk.) F. H. Chen.; Panax notoginseng (Burk.) F. H. Chen (Shanqi);Panax pseudo-ginseng Wall.var.notoginseng (Burk) Hoo et Tseng; Panaxginseng C. A. Mey (P.schinseng Nees); Panax guinquefolium L.; Radixginseng; Panax ginseng C. A. Mey; Panax schin-seng Nees; Panaxschinseng.; Panax schinseng; Panax pseudoginseng; Panax pseudoginsengjaponicus (C. A. Mey.)Hoo.&Tseng.; Panax repens. Max.; Panaxpseudoginsengjaponicus; Panax pseudoginseng ssp. Japonicus; Panaxpseudoginseng subsp.; Panax japonicus; Panax pseudoginseng var.japonicus; Panax pseudo-ginseng; Panax ginseng; Panax schinsengAcanthopanax sentocosus (Rupr. et Maxim.); Eleutherococus senticosus(Rupr. et Maxim.).; Eleutherococus senticosus; Acanthopanax senticosus;Acanthopanax seticosus Harms; Acantherococus senticocus (Rupr.et Maxim)Harms.; Eleutherococus senticocus(Rupr. Et Maxim) Maxim.; Echinopanaxelatus Nakai; Hedera senticosa

[0048] “Gancao,” as used herein, refers to extracts of gancao. It isalso known as Radix glycyrrhizae uralensis, Glycyrrhiza uralensisFischer or licorice root. A member of the botanical group glycyrrhiza isa substance that is capable of providing a similar physiologicaleffect(s) as that provided by gancao in the compositions of theinvention, and is preferably selected from a group comprising Radixglycyrrhizae uralensis; Glycyrrhiza uralensis Fischer; Glycyrrhizauralensis Fisch (Gan cao); Glycyrrhiza glabra L.; GlycyrrhizainflataBatal.; Glycyrrihiza korshiskyi G. Hrig.; Glycyrrhiza aspera Pall;Glycyrrhiza yunnanensis Cheng f. et L. K. Tai.; Glycyrrhiza malensis.

[0049] “White willow bark,” as used herein, refers to extracts of whitewillow bark. It is also known as Saliz alba caerulea.

[0050] “Black cohosh root,” as used herein, refers to extracts of blackcohosh root. It is also known as rhizome of Cimicifuga racemosa orCimicifuga racemosa. A member of the botanical group Cimicifuga is asubstance that is capable of providing a similar physiological effect(s)as that provided by black cohosh root in the compositions of theinvention, and is preferably selected from a group comprising Cimicifugaracemosa; Cimicifuga cordifolia; Cimicifuga racemosa var. cordifolia;Cimicifuga heracleifolia Komar.; Cimicifuga dahurica (Turcz) Maxim;Cimicifuga foetida L.; Actaea racemosa.

[0051] “L-carnitine,” as used herein, refers to the biochemical moleculeknown as such by persons of skill in the art. It is generally known as azwitterionic compound formed from lysine. It also refers to relatedmolecules such as L-acetyl-carnitine.

[0052] “Vitamin C,” as used herein, refers to ascorbic acid and saltsthereof.

[0053] “Vitamin E,” as used herein, refers to D alpha-tocopherol,preferably in succinate form.

[0054] “Zinc,” as used herein, refers to the form(s) of the mineralknown to persons of skill in the art to be therapeutically effective inthe body of the individual. It is preferably provided as zinc gluconate.

[0055] “Selenium,” as used herein, refers to the form(s) of the mineralknown to persons of skill in the art to be therapeutically effective inthe body of the individual. It is preferably provided as seleniumaminoate.

[0056] “Extract,” as used herein, refers to the substances obtained fromthe specified source plant, or parts thereof (for e.g., root, bark,leaves). Any method of extraction that yields extracts that retain thebiological activity of the substances contained in the extract sourcecan be used to produce extracts used in this invention. Preferably, theingredients of the compositions of the present invention are extractedas an aqueous solution. The extraction is preferably performed underconditions of high pressure, preferably from 0.5 to 12 bar, morepreferably 1 to 10 bar, most preferably 3 to 7 bar, and preferably atelevated temperatures (preferably within a range of 15° C. to 120° C.,more preferably 30° C. to 100° C., most preferably 45° C. to 75° C.).The extract is preferably treated to yield a form suitable for mixing oftwo or more substances. The form is preferably a dried powder. Thepowder form is yielded from preferably at least about a 1:10, morepreferably at least about a 1:8, most preferably at least about a 1:5concentrate of the starting solution. Concentration to powder form ispreferably achieved by evaporation to yield a dried powder form. Theextracts used in this invention can also be obtained from commercialsources such as Sun Ten Laboratories (Irvine, Calif.), Qualiherb(Cerritos, Calif.), Mayway (Oakland, Calif.), Ming Tong Herb (Oakland,Calif.) and Acta (Sunnyvale, Calif.). It is understood that any methodor conditions known in the art to yield extracts comparable ineffectiveness in enhancing therapeutic effects to those produced by thepreceding preferred extraction method can be used for the purposes ofthis invention.

[0057] Formulation of the composition

[0058] Each substance contained in the compositions provided by thisinvention is provided in an amount that lies within specificquantitative ranges herein disclosed to be effective for enhancing thetherapeutic effects of a therapeutic composition.

[0059] According to the present invention, an effective amount of acomposition comprises preferably from 100 to 1500 mg, more preferably300 mg to 1200 mg, most preferably 600 mg to 900 mg of a member of thebotanical group Daemonorops (such as xuejie); and/or preferably 50 mg to1000 mg, more preferably 200 mg to 800 mg, most preferably 400 mg to 600mg of a member of the botanical group Corydalis (such as yanhusuo).

[0060] In the various embodiments of the invention, the compositionsfurther comprise preferably from 50 mg to 1000 mg, more preferably 200mg to 800 mg, most preferably 400 mg to 600 mg of a member of thebotanical group Paeonia (such as baishaoyao); preferably 200 mg to 3000mg, more preferably 500 mg to 2000 mg, most preferably 800 mg to 1500 mgof a member of the botanical group Panax (such as shanqi); preferably 50mg to 1000 mg, more preferably 200 mg to 800 mg, most preferably 400 mgto 600 mg of a member of the botanical group glycyrrhiza (such asgancao); preferably 5 mg to 150 mg, more preferably 10 mg to 120 mg,most preferably 75 mg to 100 mg white willow bark; preferably 5 mg to150 mg, more preferably 40 mg to 120 mg, most preferably 75 mg to 100 mgof a member of the botanical group Cimicifuga (such as black cohoshroot); preferably 30 mg to 600 mg, more preferably 120 mg to 500 mg,most preferably 250 mg to 400 mg L-carnitine; preferably 10 mg to 250mg, more preferably 80 mg to 300 mg, most preferably 120 mg to 200 mgvitamin E; and/or preferably 20 mg to 400 mg, more preferably 80 mg to300 mg, most preferably 120 mg to 200 mg vitamin C.

[0061] Thus, for example, a composition may comprise preferably from 100to 1500 mg, more preferably 300 mg to 1200 mg, most preferably 600 mg to900 mg of a member of the botanical group Daemonorops (such as xuejie),and preferably 200 mg to 3000 mg, more preferably 500 mg to 2000 mg,most preferably 800 mg to 1500 mg of a member of the botanical groupPanax (such as shanqi). In another example, a composition comprisespreferably 50 mg to 1000 mg, more preferably 200 mg to 800 mg, mostpreferably 400 mg to 600 mg of a member of the botanical group Corydalis(such as yanhusuo), and preferably 200 mg to 3000 mg, more preferably500 mg to 2000 mg, most preferably 800 mg to 1500 mg of a member of thebotanical group Panax (such as shanqi).

[0062] Selection of suitable members of a particular botanical group tobe included in a composition can be achieved using methods known in theart. For example, a suitable member of the botanical group Panax wouldbe expected to be capable of providing a similar physiological effect(s)as that provided by shanqi in a composition of the invention. Such amember can be selected based on, for example, whether it is known, shownand/or suspected to possess said similar physiological effect(s). Thus,for example, a determination of whether a candidate substance can be amember of the botanical group Panax can be done based on, for example, asimilar pharmacological or medicinal classification for both thecandidate substance and shanqi. However, the activity and/or functionprovided by a particular substance, such as shanqi, need not beidentified or specified. A determination of whether a candidatesubstance can be a member of a particular botanical group, for examplethe Panax group, can also be empirical, for example, by substitutingsaid candidate substance for shanqi in a composition, and assessing therelevant therapeutic effect(s) of the composition. Such a determinationcan be done using methods and techniques known in the art.

[0063] According to this invention, the compositions can be formulatedin whatever form that retains the efficacy of the compositions forenhancing the therapeutic effects of another composition. Preferably,the compositions are packaged in the form of capsules. The capsules arepreferably of size “0”, “00”, “000”, “1”, “2”, “3” or “4.” A preferredmethod for packaging into capsules involves mixing substances (extracts,vitamin and minerals) that are preferably in powder form. The substancesare preferably mixed to at least 30%, more preferably to at least 60%,even more preferably to at least 90% mixture consistency, and mostpreferably to homogeneity. The substances in powder form are provided inthe initial mixture at ratios according to the effective quantitiesdisclosed above. Methods for mixing the substances are known in the art,including, but not limited to, stirring, agitation or vibration achievedmanually or through the aid of a machine. A preferred mixing machine isa V-mixer, preferably of 100 to 1400-liter size, more preferably of 150to 1300-liter size, and most preferably of 200 to 1200-liter size.Preferably, the resulting powder mixture is filtered to screen outparticulates (i.e., anything that a person of skill in the art wouldrecognize to be larger than powder size). A preferred filter is a{fraction (1/20)}-inch particle size filter. Preferably, the filteredmixture is packaged into capsules according to the weight desired foreach capsule. Preferably, the capsule is of size “00”. The weight ofmixture per capsule is preferably from 5 mg to 1000 mg, more preferably100 mg to 800 mg, even more preferably 400 mg to 700 mg. It isunderstood that other physical forms of the compositions of thisinvention suitable for administration to an individual can also be used,including, for example, tablets, salves or liquids, as long as thecompositions can be delivered to the target tissues in the body wherethe compositions in the preferred form described above exert theireffects.

[0064] The ingredients of the compositions can be mixed withpharmaceutically acceptable solvents, excipients and/or fillersubstances. These materials are known in the art, and are described insources such as Remington's Pharmaceutical Sciences, 18th Edition, MackPublishing (1990).

[0065] Combining Compositions of the Present Invention with ATherapeutic Composition

[0066] Compositions in any of the physical forms described above can beadministered by any method known to one of skill in the art, but oraladministration is preferred. The compositions are preferablyadministered in capsule form.

[0067] An effective amount of a composition is provided preferably infrom 1 to 8 administrations, more preferably in from 2 to 6administrations, and most preferably in from 3 to 5 administrations.Administration of an effective amount is preferably completed within 24hours. A composition can be ingested alone, or with any other substance,such as a liquid, that aids ingestion of the compositions. Ingestion ofthe compositions can be before or after food consumption. Thecompositions of the present invention can be combined with anytherapeutic composition to enhance the effects of the therapeuticcomposition in treating diseases or discomfort conditions.

[0068] In preferred embodiments, the present compositions are combinedwith compositions that are effective in treating eye discomfortsyndromes, pains and/or discomfort in joints such as the wrist, painsand/or discomfort in the neck and/or shoulder, or pains and/ordiscomfort in the back and leg. We have discovered that the compositionsof the present invention are particularly effective in enhancing thetherapeutic effects of the compositions disclosed in co-pending patentapplications entitled “Compositions And Methods For Treating EyeDiscomfort” (U.S. provisional Application Ser. No. 60/208,783; U.S.patent application Ser. No. ______, filed even date herewith);“Compositions And Methods For Treating Hand And Wrist Discomfort” (U.S.provisional Application Ser. No. 60/208,991; U.S. patent applicationSer. No. ______, filed even date herewith); “Compositions and MethodsFor Treating Neck And Shoulder Discomfort” (U.S. provisional ApplicationSer. No. 60/208,797; U.S. patent application Ser. No. ______, filed evendate herewith); and “Compositions and Methods For Treating Back And LegDiscomfort” (U.S. provisional Application Ser. No. 60/208,793; U.S.patent application Ser. No. ______, filed even date herewith), all ofwhich are hereby in their entirety incorporated by reference. Thepresent compositions enhance the therapeutic effects of thesecompositions for treating conditions such as eye discomfort syndromes,wrist strain or pain, neck or shoulder pain, and back or leg pain.Without wishing to be bound by theory, the compositions of the presentinvention enhance therapeutic effects by relaxing muscles and tendons,activating the flow of Qi and blood in the meridian and collateralsaccording to Chinese medicine, relieving rigidity of muscles andactivating collaterals and promoting blood circulation, enriching bloodand nourishing muscles and tendons, and arresting bleeding by removal ofstasis, thereby promoting the delivery of the therapeutic compositionsto target tissues when the therapeutic compositions are co-administeredwith the present compositions.

[0069] Other medical conditions for which the compositions of thepresent invention are particularly useful include post-trauma musclespasms, bleeding (internal and external), sciatic pain, swelling andbleeding due to injury and bruising, inflammatory conditions, generaland specific pain conditions. The present compositions enhance theefficacy of compositions used to treat these conditions.

[0070] The preferred timing of co-administration is administration ofthe compositions of this invention at the same time as theadministration of the therapeutic compositions. However, the timing ofco-administration can be varied according to the needs of theindividual, or in accordance with the empirical determination orexperience of the health care professional or individual.

EXAMPLES Example 1 An Illustrative Example of the Formulation of ASingle “00” Capsule, and the Production Thereof

[0071] A composition shown to enhance the effects of a therapeuticcomposition for treating neck and shoulder pains contained substances inthe indicated quantities as listed in Table 1. TABLE 1 SUBSTANCE[Commercial Source] AMOUNT (mg) Xuejie [Min Tong Herb, Oakland, CA] 133Yanhusuo [Mayway, Oakland, CA] 83 Baishaoyao [Qualiherb, Cerritos, CA]83 Shanqi [Sun Ten, Irvine, CA] 250 Gancao [Qualiherb, Cerritos, CA] 83White willow bark [Acta, Sunnyvale, CA] 10 Black cohosh root [Acta,Sunnyvale, CA] 10 L-carnitine [Acta, Sunnyvale, CA] 50 Vitamin E (DAlpha-Tocopherol 21.19 succinate) [Acta, Sunnyvale, CA] Vitamin C [Acta,Sunnyvale, CA] 30

[0072] Capsules containing the composition above were manufacturedaccording to the method used by the commercial manufacturer, Acta(Sunnyvale, Calif.). Briefly, the substances listed above, in powderform and obtained from the commercial sources indicated, were mixed ininput amounts in accordance to the ratio of the substances in thecomposition as a whole. Mixing was accomplished with a V-mixer, grindingfor 15 to 30 minutes, at a speed of 15 to 30 rpm (rounds per minute), toproduce a homogenous mixture of the input substances. Particulates(non-powder forms) were then filtered out with a {fraction (1/20)}-inchparticle size filter that separated particulates from the powder. 671 mgof the filtered mixture was then packaged into each size “00” capsule.

Example 2 Illustrative Example of Enhancement Of Therapeutic Effects ofA Composition For Treating Neck Or Shoulder Discomfort

[0073] 11 individuals with neck or shoulder pain symptoms were treatedwith the composition exemplified in Example 1 in combination with thecomposition set forth in Table 2. The composition of Table 2 isexemplified as Example 1 of co-pending patent application entitled“Compositions and Methods For Treating Neck And Shoulder Discomfort”(which is hereby incorporated herein by reference in its entirety). Theindividuals were instructed to fill out a clinical questionnaire toassess efficacy of treatment with these compositions over time. Theywere instructed to assess frequency of pain (e.g., occasional,intermittent, or constant) as a primary criterion for pain severity.They were administered the compositions for between 3 days and 3 weeks,at a daily dosage of from 2 to 9 capsules of the composition of Table 2,and at a daily dosage of from 1 to 9 capsules of the composition ofExample 1. TABLE 2 A Composition For Treating Neck And ShoulderDiscomfort SUBSTANCE [commercial source] AMOUNT (mg) Huangqi [Mayway,Oakland, CA] 33 Dangquiwei [Mayway, Oakland, CA] 33 Weilingxian[Qualiherb, Cerritos, CA] 67 Gegen [Qualiherb, Cerritos, CA] 167 Guizi[Qualiherb, Cerritos, CA] 167 Baishaoyao [Qualiherb, Cerritos, CA] 167Gancao [Qualiherb, Cerritos, CA] 17 Dazao [Mayway, Oakland, CA] 17Bilberry [Acta, Sunnyvale, CA] 10 Ginger [Qualiherb, Cerritos, CA] 17Vitamin B-1 (thiamine) [Acta, 5 Sunnyvale, CA] Vitamin B-2 (riboflavin)[Acta, 5 Sunnyvale, CA] Vitamin B-6 (pyridoxine) [Acta, 15 Sunnyvale,CA] Vitamin B-12 (cobalamin) [Acta, 0.0125 Sunnyvale, CA] Vitamin C(ascorbic acid) [Acta, 30 Sunnyvale, CA] Vitamin E (D alpha-tocopherol21.19 succinate) [Acta, Sunnyvale, CA] White willow bark [Acta,Sunnyvale, CA] 10 Quercitin [Acta, Sunnyvale, CA] 25 Selenium aminoate[Acta, Sunnyvale, CA] 20

[0074] Severity of neck pain was graded on a scale of 0 to 10. 0 wasdefined as normal neck condition and 10 was defined as severe pain. Theresults showed a clear and significant decrease in severity, and in somecases complete clearance, of pain by the end of the study. By comparingthese results to the results expected from a study wherein individualsare administered the composition of Table 2 alone, it would be clearthat the composition of Example 1 enhances the therapeutic effects ofthe composition of Table 2 in treating neck pain.

[0075] Severity of shoulder pain was graded on a scale of 0 to 10. 0 wasdefined as normal shoulder condition and 10 was defined as severe pain.The results showed a clear and significant decrease in severity, and insome cases complete clearance, of pain by the end of the study. Bycomparing these results to the results expected from a study whereinindividuals are administered the composition of Table 2 alone, it wouldbe clear that the composition of Example 1 enhances the therapeuticeffects of the composition of Table 2 in treating shoulder pain.

[0076] It is understood that the enhancing effect of the compositions ofthe present invention can be demonstrated for any therapeuticcomposition using any study protocol similar to the one described inthis Example.

Example 3 Illustrative Example Of Enhancement Of Therapeutic Effects OfA Composition For Treating Hand Or Wrist Discomfort

[0077] An individual who suffered two separate bouts of wrist pain wastreated during the course of one bout with the composition set forth inTable 3 (Bout A), and during the course of the other bout with thecomposition of Table 3 in combination with the composition exemplifiedin Example 1 of the instant specification (Bout B). The composition ofTable 3 is exemplified as Example 1 of co-pending patent applicationentitled “Compositions And Methods For Treating Hand And WristDiscomfort” (which is hereby incorporated herein by reference in itsentirety). In Bout A, 5 dosages of 2 capsules per dosage, followed by 7dosages of 1 capsule per dosage, of the composition of Table 3 wereadministered. In Bout B, the same dosage amounts were administered forthe same duration, except that the composition of Example 1 of theinstant specification was co-administered (simultaneously) at 2 capsulesper dosage for the first 5 dosages, and at 1 capsule per dosage for thefollowing 3 dosages. TABLE 3 A Composition For Treating Hand And WristDiscomfort SUBSTANCE [commercial source] AMOUNT (mg) Baishaoyao[Qualiherb, Cerritos, CA] 33.3 Fangfeng [Qualiherb, Cerritos, CA] 33.3Guizi [Qualiherb, Cerritos, CA] 50 Honghua [Qualiherb, Cerritos, CA]33.3 Chuanxiong [Qualiherb, Cerritos, CA] 50 Yuanhusuo [Mayway, Oakland,CA] 50 Dangquiwei [Mayway, Oakland, CA] 50 Gancao [Qualiherb, Cerritos,CA] 33.3 Ginger [Qualiherb, Cerritos, CA] 33.3 Huangqi [Mayway, Oakland,CA] 133 Sangzhi [Qualiherb, Cerritos, CA] 66.7 Yinyanghuo [Qualiherb,Cerritos, CA] 33.3 Weilingxian [Mayway, Oakland, CA] 66.7 Dazao [Mayway,Oakland, CA] 16.7 Vitamin B-1 (Thiamine) [Acta, 4.2 Sunnyvale, CA]Vitamin B-2 (Riboflavin) [Acta, 4.2 Sunnyvale, CA] Vitamin B-3 (Niacin)[Acta, 8.3 Sunnyvale, CA] Vitamin B-5 (Pantothenic acid) [Acta, 4.2Sunnyvale, CA] Vitamin B-6 (pyridoxine) [Acta, 33 Sunnyvale, CA] VitaminC (ascorbic acid) [Acta, 100 Sunnyvale, CA] Vitamin E (Dalpha-tocopherol 14.1 succinate) [Acta, Sunnyvale, CA] Beta-carotene[Acta, Sunnyvale, CA] 7.5 Zinc gluconate [Acta, Sunnyvale, CA] 21Quercetin [Acta, Sunnyvale, CA] 8.3 Selenium aminoate [Acta, Sunnyvale,CA] 6.7 Rice flour powder [Acta, Sunnyvale, CA] 10 Magnesium stearate NT[Acta, Sunnyvale, CA] 10

[0078] Prior to administration of the composition(s), the individual wasasked to rate the severity of her symptoms on a scale of 0 to 5, 0 beingnormal condition and 5 being severe pain. Subsequently, the individualwas asked to assess her symptoms within 4 hours after eachadministration of the composition(s). The individual was instructed toassess frequency of pain (e.g., occasional, intermittent, or constant)as a primary criterion for pain severity. If administration occurred atbedtime, symptoms were assessed the following morning.

[0079] Results of the study are provided in Table 4. TABLE 4 Severity ofWrist Pain Dosage No. 0 1 2 3 4 5 6 7 8 9 10 11 12 Bout A 4 4 4 4 4 4 44 4 4 4 3 3 (severity) Bout B 4 4 4 4 3 2 1 1 0.5 0 0 0 0 (severity)

[0080] The data show a clear and significant enhancement of therapeuticeffect when the composition of Example 1 in the instant specificationwas co-administered with the composition for treating wrist pain.

Example 4 Illustrative Example of Enhancement Of Therapeutic Effects ofA Composition For Treating Eye Discomfort

[0081] A randomized, double-blinded and controlled study is performed.Individuals suffering from eye discomfort such as dry eyes are dividedinto three groups. Individuals in the first group are administered thecomposition set forth in Table 5. The composition of Table 5 isexemplified as Example 1 of co-pending patent application entitled“Compositions And Methods For Treating Eye Discomfort” (which is herebyincorporated herein by reference in its entirety). Individuals in thesecond group are administered the composition exemplified in Example 1of the instant specification. Individuals in the third group areco-administered the compositions administered to the individuals of thefirst and second group. Preferably, a fourth group is included in whichindividuals are administered a placebo that does not contain any of thesubstances found in the compositions administered to the first andsecond group. TABLE 5 A Composition For Treating Eye DiscomfortSUBSTANCE [Commercial source] AMOUNT (mg) Fuling [Qualiherb, Cerritos,CA] 16.7 Jueminzi [Qualiherb, Cerritos, CA] 8.3 Sang ye [Qualiherb,Cerritos, CA] 33.3 Shanyao [Qualiherb, Cerritos, CA] 16.7 Shanzhuyu[Mayway, Oakland, CA] 16.7 Shudihaung [Qualiherb, Cerritos, CA] 100.0Bilberry [Acta, Sunnyvale, CA] 16.7 Danshen [Qualiherb, Cerritos, CA]16.7 Gouqizhi [Qualiherb, Cerritos, CA] 100.0 Juhua [Qualiherb,Cerritos, CA] 66.7 Baijili [Qualiherb, Cerritos, CA] 16.7 Beta-carotene[Acta, Sunnyvale, CA] 22.5 Copper gluconate [Acta, Sunnyvale, CA] 7.1Gujincao [Qualiherb, Cerritos, CA] 8.3 Magnesium stearate NF [Acta, 10.0Sunnyvale, CA] Mudanpi [Qualiherb, Cerritos, CA] 16.7 Rice flour powder[Acta, Sunnyvale, CA] 8.3 Selenium aminoate [Acta, Sunnyvale, CA] 6.7Vitamin B-2 (riboflavin) [Acta, 5.0 Sunnyvale, CA] Vitamin C (ascorbicacid) [Acta, 66.7 Sunnyvale, CA] Vitamin E (D Alpha-tocopherol 76.0succinate) [Acta, Sunnyvale, CA] Zexie [Acta, Sunnyvale, CA] 16.7 Zincgluconate [Acta, Sunnyvale, CA] 57.7

[0082] Individuals in the first group are daily administered from 1 to 6capsules of the composition of Table 5. Individuals in the second groupare daily administered from 1 to 6 of the capsules of Example 1 of theinstant specification. Individuals in the third group are dailyadministered the combined dosages of the individuals of the first andsecond group.

[0083] At least 20 individuals are tested, randomly assigned inapproximately equal number to the various groups. Individuals areevaluated to suffer from a particular eye discomfort symptom, such asdry eyes.

[0084] The study is carried out for at least 1 week. During thetreatment course, a dosage amount selected from the range of 1 to 6capsules of each composition is administered to each individual once ormultiple times daily, not exceeding 6 capsules of each composition perday. Capsules are administered before or after food consumption.

[0085] A clinical questionnaire is used to evaluate individuals' eyediscomfort symptoms. A clinical coordinator and/or physician evaluatesthe individuals' eye discomfort symptoms and fills out thequestionnaire. Evaluations can be performed daily, or more or lessfrequently depending on statistical or clinical (ability to detect ortrack symptomatic improvements) need.

[0086] Assessment of symptoms is divided into 4 grades: (1) clinicalcure, as defined as free of symptoms; (2) significant efficacy, asdefined as significantly improved symptoms (e.g., reduction of more than3 points on any one of discomfort scoring scales); (3) efficacy, asdefined as partially improved (e.g. reduction of more than 1 point onany one of discomfort scoring scales); and (4) non-efficacy, as definedas no improvement in symptoms.

[0087] The results of the groups are compared to assess any enhancedtherapeutic effects due to the co-administration of the compositionexemplified in Example 1.

Example 5 Illustrative Example of Enhancement Of Therapeutic Effects ofA Composition For Treating Wrist Discomfort

[0088] A randomized, double-blinded and controlled study is performed.Individuals suffering from wrist discomfort such as wrist pain aredivided into three groups. Individuals in the first group areadministered the composition set forth in Table 3. Individuals in thesecond group are administered the composition exemplified in Example 1of the instant specification. Individuals in the third group areco-administered the compositions administered to the individuals of thefirst and second group. Preferably, a fourth group is included in whichindividuals are administered a placebo that does not contain any of thesubstances found in the compositions administered to the first andsecond group.

[0089] Individuals in the first group are daily administered from 1 to 6capsules of the composition of Table 3. Individuals in the second groupare daily administered from 1 to 6 of the capsules of Example 1 of theinstant specification. Individuals in the third group are dailyadministered the combined dosages of the individuals of the first andsecond group.

[0090] At least 20 individuals are tested, randomly assigned inapproximately equal number to the various groups. Individuals areevaluated to suffer from a particular wrist discomfort symptom, such aswrist pain.

[0091] The study is carried out for at least 1 week. During thetreatment course, a dosage amount selected from the range of 1 to 6capsules of each composition is administered to each individual once ormultiple times daily, not exceeding 6 capsules of each composition perday. Capsules are administered before or after food consumption.

[0092] A clinical questionnaire is used to evaluate individuals' wristdiscomfort symptoms. A clinical coordinator and/or physician evaluatesthe individuals' wrist discomfort symptoms and fills out thequestionnaire. Evaluations can be performed daily, or more or lessfrequently depending on statistical or clinical (ability to detect ortrack symptomatic improvements) need.

[0093] Assessment of symptoms is divided into 4 grades: (1) clinicalcure, as defined as free of symptoms; (2) significant efficacy, asdefined as significantly improved symptoms (e.g., reduction of more than3 points on any one of discomfort scoring scales); (3) efficacy, asdefined as partially improved (e.g. reduction of more than 1 point onany one of discomfort scoring scales); and (4) non-efficacy, as definedas no improvement in symptoms.

[0094] The results of the groups are compared to assess any enhancedtherapeutic effects due to the co-administration of the compositionexemplified in Example 1.

Example 6 Illustrative Example of Enhancement Of Therapeutic Effects ofA Composition For Treating Back and Leg Discomfort

[0095] A randomized, double-blinded and controlled study is performed.Individuals suffering from back or leg discomfort such as back or legpain are divided into three groups. Individuals in the first group areadministered the composition set forth in Table 6. The composition ofTable 6 is exemplified as Example 1 of co-pending patent applicationentitled “Compositions And Methods For Treating Back And Leg Discomfort”(which is hereby incorporated herein by reference in its entirety).Individuals in the second group are administered the compositionexemplified in Example 1 of the instant specification. Individuals inthe third group are co-administered the compositions administered to theindividuals of the first and second group. Preferably, a fourth group isincluded in which individuals are administered a placebo that does notcontain any of the substances found in the compositions administered tothe first and second group. TABLE 6 A Composition For Treating Back AndLeg Discomfort SUBSTANCE [commercial source] AMOUNT (mg) Duzhong[Mayway, Oakland, CA] 33 Huainiuxi [Qualiherb, Cerritos, CA] 33Jixueteng [Qualiherb, Cerritos, CA] 117 Qiannianjian [Qualiherb,Cerritos, CA] 33 Rougui [Qualiherb, Cerritos, CA] 50 Xiquancao[Qualiherb, Cerritos, CA] 133 Jinyingzi [Mayway, Oakland, CA] 33Tougucao [Qualiherb, Cerritos, CA] 33 Duhuo [Qualiherb, Cerritos, CA]100 Weilingxian [Mayway, Oakland, CA] 67 Shenjincao [Qualiherb,Cerritos, CA] 17 Vitamin B-1 [Acta, Sunnyvale, CA] 5 Vitamin B-2 [Acta,Sunnyvale, CA] 5 Vitamin B-6 [Acta, Sunnyvale, CA] 15 Vitamin B-12[Acta, Sunnyvale, CA] 0.0125 Vitamin C (ascorbic acid) [Acta, 30Sunnyvale, CA] Vitamin E (D Alpha-Tocopherol) [Acta, 21.19 Sunnyvale,CA] Devil's Claw [Acta, Sunnyvale, CA] 10 Black cohosh [Acta, Sunnyvale,CA] 10 Selenium [Acta, Sunnyvale, CA] 20

[0096] Individuals in the first group are daily administered from 1 to 6capsules of the composition of Table 6. Individuals in the second groupare daily administered from 1 to 6 of the capsules of Example 1 of theinstant specification. Individuals in the third group are dailyadministered the combined dosages of the individuals of the first andsecond group.

[0097] At least 20 individuals are tested, randomly assigned inapproximately equal number to the various groups. Individuals areevaluated to suffer from a particular back or leg discomfort symptom,such as back or leg pain.

[0098] The study is carried out for at least 1 week. During thetreatment course, a dosage amount selected from the range of 1 to 6capsules of each composition is administered to each individual once ormultiple times daily, not exceeding 6 capsules of each composition perday. Capsules are administered before or after food consumption.

[0099] A clinical questionnaire is used to evaluate individuals' back orleg discomfort symptoms. A clinical coordinator and/or physicianevaluates the individuals' back or leg discomfort symptoms and fills outthe questionnaire. Evaluations can be performed daily, or more or lessfrequently depending on statistical or clinical (ability to detect ortrack symptomatic improvements) need.

[0100] Assessment of symptoms is divided into 4 grades: (1) clinicalcure, as defined as free of symptoms; (2) significant efficacy, asdefined as significantly improved symptoms (e.g., reduction of more than3 points on any one of discomfort scoring scales); (3) efficacy, asdefined as partially improved (e.g. reduction of more than 1 point onany one of discomfort scoring scales); and (4) non-efficacy, as definedas no improvement in symptoms.

[0101] The results of the groups are compared to assess any enhancedtherapeutic effects due to the co-administration of the compositionexemplified in Example 1.

EXAMPLE 7 Illustrative Example of Enhancement Of Therapeutic Effects ofA Composition For Treating Neck And Shoulder Discomfort

[0102] A randomized, double-blinded and controlled study is performed.Individuals suffering from neck or shoulder discomfort such as neck orshoulder pain are divided into three groups. Individuals in the firstgroup are administered the composition of Table 2. Individuals in thesecond group are administered the composition exemplified in Example 1of the instant specification. Individuals in the third group areco-administered the compositions administered to the individuals of thefirst and second group. Preferably, a fourth group is included in whichindividuals are administered a placebo that does not contain any of thesubstances found in the compositions administered to the first andsecond group.

[0103] Individuals in the first group are daily administered from 1 to 6capsules of the composition of Table 2. Individuals in the second groupare daily administered from 1 to 6 of the capsules of Example 1 of theinstant specification. Individuals in the third group are dailyadministered the combined dosages of the individuals of the first andsecond group.

[0104] At least 20 individuals are tested, randomly assigned inapproximately equal number to the various groups. Individuals areevaluated to suffer from a particular neck or shoulder discomfortsymptom, such as neck or shoulder pain.

[0105] The study is carried out for at least 1 week. During thetreatment course, a dosage amount selected from the range of 1 to 6capsules of each composition is administered to each individual once ormultiple times daily, not exceeding 6 capsules of each composition perday. Capsules are administered before or after food consumption.

[0106] A clinical questionnaire is used to evaluate individuals' neck orshoulder discomfort symptoms. A clinical coordinator and/or physicianevaluates the individuals' neck or shoulder discomfort symptoms andfills out the questionnaire. Evaluations can be performed daily, or moreor less frequently depending on statistical or clinical (ability todetect or track symptomatic improvements) need.

[0107] Assessment of symptoms is divided into 4 grades: (1) clinicalcure, as defined as free of symptoms; (2) significant efficacy, asdefined as significantly improved symptoms (e.g., reduction of more than3 points on any one of discomfort scoring scales); (3) efficacy, asdefined as partially improved (e.g. reduction of more than 1 point onany one of discomfort scoring scales); and (4) non-efficacy, as definedas no improvement in symptoms.

[0108] The results of the groups are compared to assess any enhancedtherapeutic effects due to the co-administration of the compositionexemplified in Example 1.

[0109] Although the foregoing invention has been described in somedetail by way of illustration and example for purposes of clarity ofunderstanding, it will be apparent to those skilled in the art thatcertain changes and modifications can be practiced. Therefore, thedescription and examples should not be construed as limiting the scopeof the invention, which is delineated by the appended claims.

1. A first composition for enhancing the therapeutic effects of a secondcomposition, said first composition comprising xuejie, yanhusuo,baishaoyao, shanqi, gancao, white willow bark, black cohosh root,L-carnitine, vitamin E and vitamin C.